Batoclimab for CIDP
Recruiting in Palo Alto (17 mi)
+134 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Immunovant Sciences GmbH
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin \[Ig\] or plasma exchange \[PLEX\]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.
Eligibility Criteria
Adults over 18 with active Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who meet specific diagnostic criteria can join this trial. They should not have other types of polyneuropathies, IgM paraproteinemia, certain forms of CIDP like Distal or Sensory CIDP, poorly controlled diabetes, central demyelination signs, or be on high doses of corticosteroids.Inclusion Criteria
Cohorts A and B: Motor nerve conduction criteria strongly supportive of demyelination
I have been diagnosed with a form of CIDP according to specific guidelines.
My tests show early signs of nerve damage.
+4 more
Exclusion Criteria
I have a specific type of chronic inflammatory nerve disease.
I have diabetes.
I am taking prescribed oral corticosteroids regularly.
+3 more
Participant Groups
The study tests Batoclimab's effectiveness and safety in treating CIDP. Participants will receive either Batoclimab at two different dosages or a placebo via subcutaneous injections for up to one year with various periods including washout and long-term extension phases.
18Treatment groups
Experimental Treatment
Group I: Withdrawal Period 2: Cohort D, PlaceboExperimental Treatment1 Intervention
Group II: Withdrawal Period 2: Cohort D, Dose 2Experimental Treatment1 Intervention
Group III: Withdrawal Period 2: Cohort C, PlaceboExperimental Treatment1 Intervention
Group IV: Withdrawal Period 2: Cohort C, Dose 2Experimental Treatment2 Interventions
Group V: Withdrawal Period 2: Cohort B, PlaceboExperimental Treatment1 Intervention
Group VI: Withdrawal Period 2: Cohort B, Dose 2Experimental Treatment2 Interventions
Group VII: Withdrawal Period 2: Cohort A, PlaceboExperimental Treatment1 Intervention
Group VIII: Withdrawal Period 2: Cohort A, Dose 2Experimental Treatment2 Interventions
Group IX: Treatment Period 1: Cohort D, Dose 2Experimental Treatment1 Intervention
Group X: Treatment Period 1: Cohort D, Dose 1Experimental Treatment1 Intervention
Group XI: Treatment Period 1: Cohort C, Dose 2Experimental Treatment1 Intervention
Group XII: Treatment Period 1: Cohort C, Dose 1Experimental Treatment1 Intervention
Group XIII: Treatment Period 1: Cohort B, Dose 2Experimental Treatment1 Intervention
Group XIV: Treatment Period 1: Cohort B, Dose 1Experimental Treatment1 Intervention
Group XV: Treatment Period 1: Cohort A, Dose 2Experimental Treatment1 Intervention
Group XVI: Treatment Period 1: Cohort A, Dose 1Experimental Treatment1 Intervention
Group XVII: LTE Period: Without Relapse in Period 2: Dose 2Experimental Treatment1 Intervention
Participants will receive Dose 2 for all 52 weeks.
Group XVIII: LTE Period: With Relapse in Period 2: Dose 1 and Dose 2Experimental Treatment2 Interventions
Participants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
Batoclimab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Batoclimab for:
- Thyroid Eye Disease (TED)
🇺🇸 Approved in United States as Batoclimab for:
- Thyroid Eye Disease (TED)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Site Number - 1621New Haven, CT
Site Number - 1625Aurora, CO
Site Number - 1636Fort Collins, CO
Site Number - 1631Orlando, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Immunovant Sciences GmbHLead Sponsor